Some tumors use estrogen in the body to assist with growth. Letrozole is a drug that is
prevents cells from producing estrogens. This should assist with the slowing of growth of
tumor cells. Letrozole also promotes cell destruction by inhibiting a cellular destruction
pathway.
The objectives of this study will look at the differences between the cellular destruction
pathway before and after letrozole use, and the differences in the cellular destruction
pathway in participants that have received letrozole versus those who did not. The study
will also look at a gene in all participants called Ki67. This gene is associated with the
rate of tumor cell growth. The study will measure the levels of Ki67 and compare them to
the amount of activation of the cellular destruction pathway.
Participants in this study will have undergone a diagnostic biopsy of their breast tissue.
In order to meet these objectives, one group of participants (Arm A) will not receive
letrozole. Tissue leftover from their diagnostic biopsy will be treated with RAD001
(Everolimus) in the laboratory and the effects of this drug on the cellular destruction
pathway will be studied.
The other group of participants (Arm B) will take letrozole for a minimum of 10 and maximum
of 21 days. They will have a second tumor sample taken as part of their surgical procedure
completed to remove the tumor tissue. Any differences in the cellular destruction pathway
before and after exposure to letrozole will be measured.

Phase (?)

Phase I trials: These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.

Phase II trials: A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works. Phase II studies usually focus on a particular type of cancer.

Phase III trials: These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, clinics, and cancer centers nationwide

Phase IV trials:In addition, after a treatment has been approved and is being marketed, the drug's maker may study it further in a phase IV trial. The purpose of phase IV trials is to evaluate the side effects, risks, and benefits of a drug over a longer period of time and in a larger number of people than in phase III clinical trials. Thousands of people are involved in a phase IV trial.

Please Note: Any eligibility criteria noted are subject to change. Our research nurses can provide you with the most current eligibility and exclusion criteria. Any study involvement to be undertaken must ultimately be determined on an individual basis.